U.S. patent application number 10/183697 was filed with the patent office on 2004-01-01 for suture anchor.
Invention is credited to Howe, Jonathan Emerson, Jensen, Kenneth L., Lizardi, Jose E., McAlister, Gary, Perkins, Daniel A..
Application Number | 20040002735 10/183697 |
Document ID | / |
Family ID | 29720394 |
Filed Date | 2004-01-01 |
United States Patent
Application |
20040002735 |
Kind Code |
A1 |
Lizardi, Jose E. ; et
al. |
January 1, 2004 |
Suture anchor
Abstract
A suture anchor for affixing soft tissue to bone. The anchor has
a hollow outer member, and an actuation member slidably mounted
within the outer member. The actuation member has at least two
engagement members that are pivotally mounted to the actuation
member. Proximal movement of the actuation member with respect to
the outer member causes the engagement members to move outward to a
deployed position, wherein the engagement members are deployed in
bone. A surgical suture is mounted to the anchor.
Inventors: |
Lizardi, Jose E.; (Franklin,
MA) ; Howe, Jonathan Emerson; (Mansfield, MA)
; McAlister, Gary; (Franklin, MA) ; Jensen,
Kenneth L.; (Providence, UT) ; Perkins, Daniel
A.; (Hyde Park, UT) |
Correspondence
Address: |
PHILIP S. JOHNSON
JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK
NJ
08933-7003
US
|
Family ID: |
29720394 |
Appl. No.: |
10/183697 |
Filed: |
June 27, 2002 |
Current U.S.
Class: |
606/232 |
Current CPC
Class: |
A61F 2002/0888 20130101;
A61B 17/7266 20130101; A61F 2/0811 20130101; A61B 2017/0435
20130101; A61B 17/0401 20130101; A61B 2017/0409 20130101; A61B
2017/0412 20130101; A61B 2017/0414 20130101 |
Class at
Publication: |
606/232 |
International
Class: |
A61B 017/04 |
Claims
We claim:
1. A suture anchor, comprising: an outer member having a proximal
end, a distal end, an inner cavity, an outer surface, and an inner
surface; a distal nose member extending from the distal end of the
outer member; an opening in the proximal end of the outer member in
communication with the inner cavity; a pair of engagement member
slots in said outer member extending through the outer surface and
in communication with the inner cavity, said slots having a
proximal end and a distal end; an actuation member slidably mounted
in the cavity of the outer member, the actuation member having a
proximal end, a distal end, and an outer surface; a cavity in said
actuation member; a pivot pin mounted in the cavity of the
actuation member, the pin member having opposed ends and an outer
surface; a pair of engagement members pivotally mounted in the
cavity of the actuation member about the pivot pin, each engagement
member having a proximal end, a distal end, and an outer surface;
and, a camming surface extending distally in the engagement cavity,
wherein the actuation member is moveable from a first distal
position partially within the cavity of the outer member wherein
the engagement members are contained within the outer member to a
second proximal position partially within the cavity of the outer
member wherein at least the proximal ends of the engagement members
extend out through the slots of the outer member such that said
engagement members may engage bone.
2. The anchor of claim 1 additionally comprising a suture mounting
opening in the actuation member.
3. The anchor of claim 1 additionally comprising a surgical suture
mounted thereto.
4. The anchor of claim 1 wherein the engagement members comprise an
arcuate shape.
5. The suture anchor of claim 1 wherein the proximal ends of the
engagement members comprise a piercing edge.
6. The suture anchor of claim 1 wherein the outer member
additionally comprises a pair of pin receiving slots in
communication with the inner cavity of the outer member, the slots
having opposed sides and opposed ends.
7. The suture anchor of claim 6, wherein the ends of the pins are
contained within the suture slots.
8. The suture anchor of claim 6, wherein the ends of the pins are
in frictional contact with the sides of the slots.
9. The anchor of claim 1, wherein the engagement member slots
comprise a camming surface extending from the proximal ends.
10. The anchor of claim 1, wherein the engagement members have an
indentation in the distal ends, and a camming surface about the
indentation.
11. A method of affixing soft tissue to bone, the method
comprising: providing a suture anchor, the suture anchor
comprising: an outer member having a proximal end, a distal end, an
inner cavity, an outer surface, and an inner surface; a distal nose
member extending from the distal end of the outer member; an
opening in the proximal end of the outer member in communication
with the inner cavity; a pair of engagement member slots in said
outer member extending through the outer surface and in
communication with the inner cavity, said slots having a proximal
end and a distal end; an actuation member slidably mounted in the
cavity of the outer member, the actuation member having a proximal
end, a distal end, and an outer surface; a cavity in said actuation
member; a pivot pin mounted in the cavity of the actuation member,
the pin member having opposed ends and an outer surface; a pair of
engagement members pivotally mounted in the cavity of the actuation
member about the pivot pin, each engagement member having a
proximal end, a distal end, and an outer surface; a camming surface
extending distally in the engagement cavity; and, a surgical suture
mounted to the actuation member, wherein the actuation member is
moveable from a first distal position within the cavity of the
outer member wherein the engagement members are contained within
the outer member to a second proximal position within the cavity of
the outer member wherein at least the proximal ends of the
engagement members extend out through the slots of the outer member
such that said engagement members may engage bone; accessing a bone
and drilling a hole into the bone; inserting the suture anchor into
the hole in the bone and deploying the engagement members into bone
surrounding the hole in the bone by pulling proximally on the
sutures causing the actuation member to move proximally with
respect to the outer member to the second proximal position; and,
engaging soft tissue with the suture and approximating the soft
tissue to the bone.
12. A suture anchor, comprising: an outer member having a proximal
end, a distal end, an inner cavity, an outer surface, and an inner
surface; an opening in the proximal end of the outer member, and an
opening in the distal end of the outer member, wherein both holes
are in communication with the inner cavity; a pair of engagement
member slots in said outer member extending through the outer
surface and in communication with the inner cavity, said w slots
having a proximal end and a distal end; an actuation member
slidably mounted in the cavity of the outer member, the actuation
member having a proximal end, a distal end, and an outer surface; a
distal nose member extending from the distal end of the actuation
member; a cavity in said actuation member; a pivot pin mounted in
the cavity of the actuation member, the pin member having opposed
ends and an outer surface; a pair of engagement members pivotally
mounted in the cavity of the actuation member about the pivot pin,
each engagement member having a proximal end, a distal end, and an
outer surface; and, a camming surface extending distally in the
engagement cavity, wherein the actuation member is moveable from a
first distal position partially within the cavity of the outer
member wherein the engagement members are contained within the
outer member and wherein the distal nose member of the actuation
member extends out through the distal opening of the outer member
to a second proximal position partially within the cavity of the
outer member wherein at least the proximal ends of the engagement
members extend out through the slots of the outer member such that
said engagement members may engage bone.
13. The anchor of claim 12 additionally comprising a suture
mounting opening in the actuation member.
14. The anchor of claim 12 additionally comprising a surgical
suture mounted thereto.
15. The anchor of claim 12 wherein the engagement members comprise
an arcuate shape.
16. The suture anchor of claim 12 wherein the proximal ends of the
engagement members comprise a piercing edge.
17. The suture anchor of claim 12 wherein the outer member
additionally comprises a pair of pin receiving slots in
communication with the inner cavity of the outer member, the slots
having opposed sides and opposed ends.
18. The suture anchor of claim 17, wherein the ends of the pins are
contained within the suture slots.
19. The suture anchor of claim 18, wherein the ends of the pins are
in frictional contact with the sides of the slots.
20. The anchor of claim 12, wherein the engagement member slots
comprise a camming surface extending from the proximal ends.
21. The anchor of claim 1, wherein the engagement members have an
indentation in the distal ends, and a camming surface about the
indentation.
22. The anchor of claim 1 additionally comprising a second set of
engagement members mounted in the cavity of the actuation member
and a second pair of engagement member slots in the outer
member.
23. The anchor of claim 12 additionally comprising a second set of
engagement members mounted in the cavity of the actuation member
and a second pair of engagement member slots in the outer member.
Description
TECHNICAL FIELD
[0001] The field of art to which this invention pertains is medical
devices and surgical procedures for repairing soft tissue injuries,
more specifically, suture anchors and methods of using these suture
anchors to affix soft tissue to bone.
BACKGROUND OF THE INVENTION
[0002] Suture anchor devices are known in the art of arthroscopy
and orthopedic surgery for use in repairing soft tissue injuries in
joints. A joint, such as the knee, the elbow, or the shoulder,
contains tissue such as ligaments, tendons and cartilage, which
allows the joint to function. For example, the soft tissue permits
joint articulation, and the transmission and absorption of forces.
Frequently, as a result of trauma caused by an accident or
overloading of a joint during sports activities, the soft tissue
may become damaged. It is not unusual in a sports related injury to
have tearing of cartilage or the separation of a tendon or ligament
from a bone surface. Such injuries tend to result in loss of joint
function to a greater or lesser degree, and typically require some
sort of surgical intervention and remediation to provide normal
joint function.
[0003] It is typical in this art to repair soft tissue injuries
using medical devices that are commonly known as suture anchors. A
suture anchor typically consists of an implantable member that
engages bone and a suture mounted to the implantable member, for
example, through an eyelet.
[0004] The suture anchors are typically employed in a surgical
procedure in the following manner. The surgeon, after surgically
accessing the damaged joint, drills a bore hole, typically a blind
hole, into a bone adjacent to the joint where the soft tissue
injury has occurred.
[0005] Then the surgeon inserts the suture anchor into the drilled
hole and manipulates the anchor to assure engagement therein, such
that the anchor is stationary in the hole. Next the surgeon passes
the suture through the soft tissue, typically by using a surgical
needle attached to the suture, and approximates the soft tissue
against the surface of the bone, thereby completing the
reattachment of the soft tissue. After such a surgical repair, the
body's healing response will cause a natural healing and
re-attachment of the soft tissue to the bone surface, and the
damaged joint will typically regain normal function.
[0006] Although there are numerous suture anchors known in this art
for soft tissue re-attachment, there is a constant need for novel
suture anchors having advantageous characteristics.
SUMMARY OF THE INVENTION
[0007] Therefore, it is an object of the present invention to
provide a novel suture anchor, which is deployed by manipulation
after insertion into a drilled hole in bone.
[0008] It is another object of the present invention to provide a
suture anchor, which is deployable at a specific location within
such a bone hole.
[0009] It is yet a further object of the present invention to
provide a suture anchor that is removable from such a bone hole
subsequent to deployment.
[0010] Accordingly, a suture anchor is disclosed. The suture anchor
has an outer member having a proximal end, a distal end, an inner
cavity, an outer surface, and an inner surface. An optional distal
nose member extends from the distal end of the outer member. There
is an opening in the proximal end of the outer member in
communication with the inner cavity. A pair of engagement member
slots in the outer member extends through the outer surface. The
slots are in communication with the inner cavity, and each slot has
a proximal end and a distal end. The anchor has an actuation member
slidably mounted in the cavity of the outer member. The actuation
member has a proximal end, a distal end, and an outer surface.
There is a cavity in the actuation member. A pivot pin is mounted
in the cavity of the actuation member. The pin member has opposed
ends and an outer surface. A pair of engagement members is
pivotally mounted in the cavity of the engagement member about the
pivot pin. Each engagement member has a proximal end, a distal end,
and an outer surface. There is a camming surface that extends
distally into the cavity of the actuation member. The actuation
member is moveable from a first distal position wherein the
engagement members are substantially contained within the outer
member to a second proximal position wherein at least the proximal
ends of the engagement members extend out through the slots of the
outer member such that said engagement members may engage bone.
[0011] Still yet another aspect of the present invention is a
method of affixing soft tissue to bone utilizing the suture anchors
of the present invention, such as that described above. An anchor
of the present invention is deployed in a bore hole drilled in bone
and the anchor is deployed in a position within the bone bore hole
such that the engagement members are deployed in bone surrounding
the bone bore hole. Sutures mounted to the suture anchor are then
used to affix soft tissue to a surface of the bone.
[0012] These and other aspects and advantages of the present
invention will become more apparent from the following description
and accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] FIG. 1 is a perspective view of a preferred embodiment of a
suture anchor of the present invention illustrated prior to
deployment.
[0014] FIG. 2 is a perspective view of a suture anchor of FIG. 1 in
a fully-deployed position wherein the engagement members are
deployed outwardly.
[0015] FIG. 3 is an exploded perspective view of the suture anchor
of FIG. 1.
[0016] FIG. 4 is a cross-sectional view of the outer member of the
anchor of FIG. 3 taken along view line 4-4.
[0017] FIG. 5 is a cross-sectional view of the actuation member of
FIG. 3 taken along view line 5-5.
[0018] FIG. 6 is a perspective view of an outer member and an
engagement member shown in cross-section, prior to assembly.
[0019] FIG. 7 is a perspective view of the outer member and the
actuation member of FIG. 6, illustrating the actuation member
inserted into the outer member, and also illustrating the
engagement members prior to assembly.
[0020] FIG. 8 is a cross-sectional perspective view illustrating
the assembly of the engagement members into the cavity of the
actuation member of FIG. 7, and also illustrating the pin
member.
[0021] FIG. 9 illustrates a cross-sectional perspective view of the
suture anchor of FIG. 8 fully assembled with the pin emplaced and a
suture mounted to the anchor.
[0022] FIG. 10 is a side view of a suture anchor of the present
invention in the undeployed configuration illustrating the end of
the pin member in the pin slot, and the end of the engagement
members contained within the engagement member slots.
[0023] FIG. 11 illustrates the anchor of FIG. 10 rotated 90.degree.
.sup.about the longitudinal axis illustrating the engagement
members protruding into the engagement member slots of the outer
member.
[0024] FIG. 12 illustrates an anchor of the present invention
mounted to an insertion tool.
[0025] FIG. 13 illustrates an anchor of the present invention
mounted to the distal end of an insertion tool immediately prior to
insertion into a bone bore hole drilled in a bone adjacent to a
joint.
[0026] FIG. 14 is a magnified side view of the anchor and distal
end of the insertion tool of FIG. 13 rotated 90.degree. about the
longitudinal axis to illustrate the suture and the arc engagement
members prior to deployment.
[0027] FIG. 15 illustrates the suture anchor partially inserted
into the bone bore hole, with the anchor in the undeployed
position.
[0028] FIG. 16 illustrates the suture anchor emplaced in the bone
bore hole at the desired deployment location prior to deployment of
the anchor and the engagement members.
[0029] FIG. 17 illustrates the anchor of FIG. 16 with the anchor at
the deployment location, with the anchor deployed and having the
engagement members fully-deployed and engaged in bone surrounding
the bore hole.
[0030] FIG. 18 illustrates the deployed anchor of FIG. 17, with the
distal end of the insertion tool removed from the proximal end of
the anchor.
[0031] FIG. 19 illustrates the anchor deployed in the bore hole
with the engagement members deployed in bone and having suture
extending out from the bone bore hole, ready to mount or affix
tissue to the surface of the bone.
[0032] FIG. 20 is a perspective view illustrating an alternate
embodiment of a suture anchor of the present invention having four
engagement members; the anchor is in the undeployed position.
[0033] FIG. 21 is a perspective view of the anchor of FIG. 20 in
the fully-deployed position wherein all four engagement members are
fully rotated out of the engagement member slots.
[0034] FIG. 22 is a side view of the anchor of FIG. 20.
[0035] FIG. 23 is a side view of the anchor of FIG. 22 rotated 90
degrees about the longitudinal axis to illustrate the engagement
members and the pin member and pin slot.
[0036] FIG. 24 is an alternate embodiment of a suture anchor of the
present invention wherein the distal end of the outer member is
open, and the distal end of the actuation member is conically
shaped and extends through the distal open end of the outer member;
the anchor is in the undeployed position.
[0037] FIG. 25 illustrates the anchor of FIG. 24 in the deployed
position.
[0038] FIG. 26 is a side view of the anchor of FIG. 24 illustrating
the engagement members and the pin members in then undeployed
position, wherein the distal end of the actuation member extends
through and out of the distal opening of the outer member.
[0039] FIG. 27 is a side view of the anchor of FIG. 26 rotated 90
degrees about the longitudinal axis.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0040] The suture anchors of the present invention are made from
conventional biocompatible materials known in this art and
equivalents thereof. The biocompatible materials may be absorbable
or non-absorbable. Examples of biocompatible, non-absorbable
materials include metals such as titanium, surgical stainless
steel, Nitinol, and the like and combinations thereof, equivalents
thereof and the like. The biocompatible non-absorbable materials
may include conventional ceramics such as alumina, equivalents
thereof and the like. The anchors of the present invention may also
be made from conventional nonabsorbable composite materials and the
like.
[0041] The biocompatible bioabsorbable and bioresorbable materials
that can be used to manufacture the suture anchors of the present
invention include conventional, known bioabsorbable and
bioresorbable polymers including tricalcium phosphate, polylactic
acid, polyglycolic acid and the like and equivalents thereof and
combinations thereof. If desired, the suture anchors of the present
invention may be made from both bioabsorbable and non-absorbable
components. In a preferred embodiment, surgical sutures are mounted
to the one or more of the ends of the sutures.
[0042] The sutures useful for mounting to the suture anchors of the
present invention will be conventional surgical sutures made from
conventional biocompatible materials. The materials may be
absorbable or nonabsorbable, and natural or synthetic. Absorbable
materials include polylactic acid, polydioxanone, equivalents
thereof and the like. Nonabsorbable materials include polyester and
the like. The sutures may be braided or monofilament.
[0043] The suture anchors of the present invention are manufactured
in a conventional manner using conventional manufacturing
techniques such as machining, casting, molding, extruding and the
like and equivalents thereof. The manufacturing techniques employed
will be dependent upon the materials of construction selected.
[0044] Referring now to FIGS. 1-4, a suture anchor 10 of the
present invention is seen. Anchor 10 is seen to have outer member
20. Outer member 20 is seen to be a hollow elongated member having
a proximal end 25 and a distal end 28. Extending distally from
distal end 28 is the nose member 30 having a substantially conical
configuration. If desired nose member 30 may have other geometric
configurations including arcuate, flat, bullet-shaped,
spade-shaped, curved, semicircular, flat, pyramidal, etc., and
combinations thereof. Member 20 is seen to have a rod-like shape
having a preferred circular cross-section. If desired, member 20
may have other cross-sections including elliptical, polygonal,
square, rectangular, triangular, and combinations thereof. Member
20 is seen to have outer surface 22, inner surface 24 and
longitudinal axis 35. The member 20 has inner cavity 40 having
proximal end 42 and distal end 44. Proximal end 42 of cavity 40 is
in communication with the opening 38 in proximal end 25. Distal end
44 of cavity 40 is adjacent to and bounded by distal section 27 of
inner surface 24. Member 20 is also seen to have side slots 50
having openings 54 that extend through member 20 and are in
communication with inner cavity 40. Slots 50 are seen to have
opposed sides 51, distal end 53 and proximal end 52. Extending
distally from proximal end 52 is the camming surface 57. Also
extending through the side wall of member 20 are the opposed pin
slots 60. Pin slots 60 are seen to have sides 62, and proximal end
63 and distal end 64. Opposed ends 63 and 64 are preferably curved
or arcuate, but may be squared off or have other geometric
configurations. Pin slots 60 are seen to have openings 66 in
communication with inner cavity 40. The optional instrument
receiving slots 31 are seen to be contained in either side of the
proximal end 25 of member 20. The opposed key receiving slots 31
are seen to have bottoms 32, sides 33, and side openings 39 and top
openings 38. Openings 39 extend through and are in communication
with proximal section 42 of cavity 40.
[0045] Anchor 10 is also seen to have actuation member 70.
Actuation member 70 is seen to be a rod-like member having a
proximal end 72, a distal end 74, an outer surface 77 and a
longitudinal axis 79. Actuation member 70 preferably has a circular
cross-section, but may if desired have other geometric
cross-sections including elliptical, polygonal, rectangular,
triangular, square, and combinations thereof. Distal end 74 is seen
to preferably have a substantially flat end surface 80, but may
have other configurations as well including for example arcuate or
rounded, conical, pyramidal, etc. Actuation member 70 is seen to
have engagement member receiving cavity 90 for receiving and
mounting engagement members 150. The cavity 90 is seen to have
distal section 94 and proximal section 98. The cavity 90 is seen to
communicate with opposed lateral openings 100. Lateral openings 100
are seen to have an elongated shape, and further have opposed sides
104 and opposed rounded ends 105. Ends 105 are preferably rounded
but may have other geometric configurations. Extending distally
into the proximal section 98 of cavity 90 is the camming member 110
having camming surfaces 112. Camming surfaces 112 are seen to have
proximal ends 114 and distal ends 116 that intersect to form distal
surface 118. The camming surfaces 122 are seen to have a convex
inward curve, but may have other configurations including for
example parallel surfaces extending to distal ends 116. The member
70 is also seen to have a pair of opposed pin hole openings 120
having passages 122 that extend inward from outer surface 77, such
that passages 122 are in communication with cavity 90. The openings
120 are seen to be circular in shape, but may have other
configurations including square, elliptical, polygonal,
rectangular, etc., combinations thereof and the like.
[0046] The suture mounting opening 130 is seen to extend
transversely through member 70 adjacent to the proximal end 74.
Suture mounting opening 130 is seen to have bottom 132, top 134,
passage 135 and opposed openings 137 in communication with passage
135. Optionally, although not illustrated in the drawings, suture
mounting opening can be replaced with other conventional suture
mounting members such as a conventional eyelet extending proximally
from proximal end 72 of member 70 or from the proximal end of
member 20, a suture loop mounted to the member 70 or the member 20,
etc. The suture containment slots 140 are seen to extend distally
from proximal end 74 through to opening 130. The slots 140 are seen
to extend radially into member 70 through outer surface 77. The
slots 140 are seen to have proximate open ends 142, distal ends
144, opening 145 and inner surface 146 having bottom 147. Mounted
to anchor 10 is a suture 160 that is partially contained in slots
140 and extends through suture mounting opening 130. A suture 180
is seen to pass through mounting opening 130 and to be partially
contained within slots 140.
[0047] Mounted in the cavity 90 of actuation member 70 are the
engagement members 150. Engagement members 150 are seen to be
rod-like members having an arcuate shape. Although not preferred,
the members 150 may be tubular in nature having inner longitudinal
passages or lumens. In addition, although it is preferred that the
engagement members 150 have a curved or arcuate configuration, the
engagement members 150 may have other configurations including
straight, combinations of straight and arcuate sections, curved,
parabolic, semi-circular, combinations thereof and the like. The
engagement members 150 are seen to have proximal ends 152, distal
ends 156 and outer surfaces 160. Proximal ends 152 are seen to be
angulated in order to form piercing edges 154. Proximal ends 152
are seen to have flat endfaces 155. However, if desired, proximal
ends 152 may be configured to be blunt, rounded, pointed, etc.
Distal ends 156 are seen to have rounded end faces 157, but
endfaces 157 may have other configurations such as flat, etc. Each
engagement member 150 is seen to have camming indentation 162
extending into the member 150 adjacent to distal end 156. The
indentations 162 are seen to have camming surfaces 165. Also
mounted in member 70 is the pin member 170. Pin member 170 is seen
to be an elongated cylindrically shaped pin having opposed ends 172
and outer surface 176. Pin member 170 is seen to extend through the
passages 122 of pin hole openings 120 and into cavity 90 at distal
end section 94. The outer surface 176 of pin member 170 is seen to
engage camming surfaces 165 of engagement members 150.
[0048] The engagement members 150 are mounted in cavity 94 of
member 90 such that the camming indentations 162 are adjacent to
pin 170, and surfaces 165 engage outer surface 176. Actuation
member 70 is slidably mounted in cavity 40 of outer member 20 such
that the actuation member is movable longitudinally from a first
distal position wherein the engagement members 150 are not deployed
to a second proximal position wherein the engagement members 150
are deployed radially outwardly through slots 50 of member 20. The
ends of pin member 170 are slidable within slots 60. The width of
slots 60 is sufficient to provide for effective sliding motion of
pin ends 172. Optionally, the width of slot 60 may be such that an
interference or friction fit is provided between the sides 62 of
slot 60 and the surface 176 of pin member 170 at pin ends 172. This
will result in an increased force being required to proximally move
the actuation member 70 in order to deploy the engagement members.
This increased force required to move the actuation member 70 may
provide the user with improved control of the deployment of the
anchor 10 and deter or prevent inadvertent deployment.
[0049] The suture anchors 10 of the present manner operate
mechanically in the following manner. Prior to deployment, the
actuation member 70 is located in an initial distal position within
cavity 40 of outer member 20. The engagement members are
substantially contained with cavity 90 of actuation member 70, with
the proximal ends 152 of engagement members 150 extending into and
contained within the slots 50 of outer member 20. If desired,
engagement member 150 can be completely contained within cavity 90
prior to deployment and not extend into slots 150. Pin ends 172 are
seen to be contained 29 within in slots 160 in an initial distal
position. If desired, although not preferred, pin ends 172 may
extend out from slots 60 above the surface 22 of outer member 20.
In order to deploy the anchor 10, and cause the engagement members
150 to be deployed into surrounding bone, a proximal force is
exerted upon the actuation member 70, preferably by pulling
proximally on a suture mounted to the actuation member 70 such as
suture 180. The proximal force caused the member 70 to slide
proximally in cavity 40, with outer surface 77 sliding against
inner surface 24 of member 20. The proximal motion causes the outer
surfaces 160 of engagement members 150 to contact camming surfaces
112 of member 70 and camming surfaces 57 of slots 150. As the
actuation member 70 moves proximally, the pin ends 172 move
proximally in slots 160. The camming surfaces 112 and 57 cause the
engagement members 150 to pivot about pin 170 and rotate radially
outwardly though and out of slots 50. The camming surface 165 of
indentation 162 is in contact with and slides over outer surface
176 of pin 170 during employment. The engagement members are fully
deployed when the proximal movement of the member 70 is stopped by
pin ends 172 engaging the proximal end 63 of slot 60.
[0050] The suture anchors 10 are assembled in the following manner.
Referring to FIGS. 6-9, initially the outer member 20 and the
actuation member 70 are axially aligned. Then the actuation member
70 is inserted into cavity 40 of outer member 20, and displaced to
a distal position. Next, the engagement members 130 are introduced
through pin slots 60 on outer member 20 and into cavity 90 such
that members 150 engage camming surfaces 122 on engaging member 70.
The distal ends 156 are mounted such that the indentations 162 are
proximate to the pin openings 120. Finally, the anchor assembly 10
is completed by introducing pin member 170 through slots 60 and
into pin hole openings 120, such that the pin extends through outer
member 20 and actuation member 70, and pin ends 172 are preferably
contained within slots 60.
[0051] The size of the anchors 10 of the present invention will
depend upon the surgical application and the individual
characteristics of the patient and will be sufficient to
effectively provide anchoring against a load. For example, the
anchor dimensions will be larger for applications around a joint
where the forces are expected to be larger such as 30 pounds, and
smaller for applications where the anchor will be subjected to
smaller forces such as 2 pounds. By way of example and not
limitation, the diameters of the anchors can range from about 1.3
mm to about 5 mm, and the lengths of the anchors can range from
about 4 mm to about 18 mm.
[0052] Referring now to FIG. 12., an insertion device 200 useful in
inserting the suture anchors 10 of the present invention into bone
bore holes is illustrated. The insertion device 200 is seen to have
a handle 210 having a distal end 214 and a proximal end 212.
Extending from the proximal end 212 of handle member 210 is the
elongated member 220 having proximal end 222 and distal end 224.
Member 220 is preferably a solid rod-like member having a lumen or
passage therein, but may be a tubular member having a lumen.
Although preferably having a circular cross-section, the member 220
may have other geometric cross-sections including elliptical,
square, polygonal, rectangular, arcuate, combinations thereof and
the like. Extending from the distal end 224 of member 220 is the
mounting member 240. Mounting member 240 is seen to have proximal
end 222 and distal end 244 having mounting key projections 246. The
mounting member is preferably a rod-like member having a circular
cross-section, but may have other cross-sections as described
previously, and may be tubular. The anchor 10 is mounted to the
distal end 244 of mounting member 240 by inserting the key
projections 246 into key receiving slots 31 of outer member 20. Key
receiving slots 31 provide a friction fit to retain key projections
246. Mounting member 240 is also seen to have suture containment
slots 245 extending therein.
[0053] The proximal ends of the sutures 180 are retained by handle
210 within cavity 215, which is covered by slidably mounted cover
member 250. In use, the cover member 250 can be slid proximally to
uncover cavity 215, and suture 180 may then be withdrawn for use in
the surgical procedure. Alternatively, the sutures 180 can be
retained by a conventional retention member such as a hook, etc. on
the outer surface of handle 210, and removed from engagement with
the retention member for use.
[0054] The use of the suture anchors 10 of the present invention is
illustrated in FIGS. 13-19. As seen in FIG. 13, the anchor 10
mounted to instrument 200 (see FIG. 14) is located proximal to a
bone 300. The anchor 10 is in the undeployed position. Bone 300 is
seen to have outer surface 301, and interior cancellous bone
material 305 beneath outer cortex bone material 304. Bone bore hole
310 is seen to have cavity 312, proximal open end 314 and bottom
316. Cavity 312 of bone bore hole 310 is seen to be surrounded by
bone surface 318. Next, as seen in FIG. 15, the surgeon moves the
anchor 10 mounted to the distal end 224 of the elongated member 220
of insertion instrument 200 to a position within the cavity 312 of
bone bore hole 310. If desired the anchor 10 can be deployed at any
position within the bone bore hole 310 below the outer cortex layer
314. When the surgeon determines the desired depth within bone bore
hole 310, the distal end 244 of support tube 240 is contacted with
bone surface 318 surrounding open end 314 as seen in FIG. 16. The
anchor up until this point remains in the undeployed configuration.
Deployment of the anchor 10 in the bone bore hole 310 is
illustrated in FIGS. 17-19. The deployment is initiated by exerting
a force in the proximal direction upon the sutures 180. This causes
actuation member 70 to slide proximally in outer member 20, thereby
causing a camming action that pivots engagement members radially
outward such that the proximal ends penetrate through the bone
surface 318 and into the surrounding cancellous bone 305. The
anchor is fully deployed when the maximum proximal movement has
been achieved by the actuation member 70, as determined by the pin
end 172 engaging the proximal end of pin slot 60. At full
deployment a substantial section of each engagement member is
deployed in the cancellous bone 305. After the anchor 10 has been
completely deployed, the key projections 246 of instrument 200 are
disengaged from the slots 31 of anchor 10 by pulling and/or
twisting instrument 200, and the instrument 200 is then withdrawn
from bore hole 310. As seen in FIG. 19, the anchor is fully
deployed in the bore hole such that the anchor is in a fixed
position and ready for the affixation of soft tissue to the surface
301 of the bone 300 with the sutures 160.
[0055] If desired, the anchor 10 may be removed from bore hole 310
after deployment of the engagement members 150. The distal end of
the insertion device 200 is inserted into the bore hole 310 so that
the key members engage the openings 31. Then, actuation member 70
is displaced distally by moving the instrument 200 distally to
retrieve the engagement members 150 by causing the distal movement
actuation member 70, causing the members 150 to disengage form the
bone 305 and displace inwardly into slots 50 of outer member 20 and
cavity 90 of actuation member 70. At this point the anchor device
is not engaged with the surrounding material. The anchor 10 is
withdrawn from the bone hole.
[0056] The bone bore holes into which a suture anchor of the
present invention can be deployed will have a diameter and depth to
provide for sufficiently effective anchoring and emplacement. These
parameters will depend upon the diameter of the anchor in the
undeployed and deployed configurations, as well as the length of
the anchor. For example, if the anchor has an undeployed diameter
of 2.3 mm, and a deployed overall diameter of 6.5 mm, the diameter
of the bore hole can range from about 2.4 mm to about 2.9 mm mm.
The length of the bore hole will typically be determined by the
surgeon for a sufficiently effective depth, and will typically
range from about 1 to about 2 times the length of the anchor.
[0057] The following examples are illustrative of the principles
and practice of the present invention although not limited
thereto.
EXAMPLE 1
[0058] A patient is prepared for arthroscopic surgery for a repair
of a soft tissue injury in the patient's rotator cuff in the
following manner. The patient is placed in a lateral position, or
in a semi-sitting (beach chair) position, on a standard operating
room table. After skin preparation and draping, full exposure of
the coracoid process anteriorly and the entire scapula posteriorly
is obtained. A standard posterior gleno-humeral arthroscopy portal
is employed. An 18 gauge spinal needle is inserted toward the
coracoid process anteriorly, in order to enter the gleno-humeral
joint. The joint is inflated with sterile saline, and free outflow
of fluid is confirmed as the inflating syringe is removed. Prior to
making all portal incisions, the skin and subcutaneous tissue are
infiltrated with 1% Lidocaine with Epinephrine, in order to reduce
bleeding from the portals. The arthroscope cannula is inserted in
the same direction as the spinal needle into the joint and free
outflow of fluid is confirmed. Accessory portals may be inserted
according to the preference of the surgeon. An initial diagnostic
arthroscopy is conducted in order to identify the thickness and
size of the tear. Through the lateral portal the edges of the cuff
tear are debrided back to healthy tissue using an arthroscopic
shaver. The bony bed is prepared on the greater tuberosity by
roughening the cortical surface with a 5.5 mm burr to obtain
punctuate bleeding and aid in the biologic reattachment of rotator
cuff to bone. A drill is inserted through the suture punch cannula
and used to pre-drill anchor insertion points on the greater
tuberosity. The pre-drilled holes are typically 2.4 mm to 2.7 mm in
diameter, and approximately 15 mm deep, depending on the dimensions
of the preferred anchor and the nature of the bone. The suture
anchors 10 of the present invention is inserted through the cannula
and into the drill hole on the greater tuberosity. The engagement
members 150 are deployed by pulling on the sutures 180 with a force
of 2-10 lbs., while maintaining pressure on the inserter to
maintain the position of the suture anchor in the drilled hole. The
inserter is then withdrawn with a force of 2-10 lbs. to separate
the suture anchor from the inserter shaft. Fixation is confirmed by
tugging on the sutures with a force of 2-10 lbs. After the
engagement members have been deployed in the bone surrounding the
drilled hole, and the anchor is in a secured immobile position, the
surgeon completes the surgical procedure for each anchor 10 by
passing the two suture limbs of suture 180 through the
supraspinatus tendon approximately 5 mm apart. A grasper is used
through the lateral portal to pull the cuff tendon laterally onto
the tuberosity in preparation for knot tying. A knot pusher is used
to push appropriate knots down onto the tendon while maintaining
lateral tension with the grasper. The two limbs of the suture 180
are cut with a suture cutter to complete the procedure. The tension
of the suture maintains the soft tissue against the surface of the
bone. The tension is maintained by the suture anchor 10, which is
in a fixed position in the bore hole as a result of the deployment
of the engagement members.
EXAMPLE 2
[0059] A second patient undergoes a similar surgical procedure to
that described in Example 1. During the procedure, and after
emplacement and engagement of suture anchor 10 in the drilled blind
bore hole, it is necessary to remove the deployed anchor 10. The
surgeon removes anchor 10 in the following manner. The insertion
device 200 is positioned adjacent to the proximal end of the suture
anchor 10, in alignment with axis of the device. The insertion
device 200 is reattached to the anchor by pressing the distal tip
of the inserter 200 onto the proximal end of the suture anchor 10
in openings 31. Continued insertion pressure is applied so that as
the suture anchor 10 moves deeper into the drilled hole, the
engagement members 150 retract into the slots 50 of outer member 20
and into cavity 90 of actuation member 70 of the suture anchor 10.
The suture anchor 10 is then removed from the drill hole by
removing the inserter/anchor assembly through the cannula.
[0060] An alternate embodiment of a suture anchor of the present
invention is seen in FIGS. 20-23. The anchor 400 is seen to be
similar in structure and operation to anchor 10. However, anchor
400 is seen to have a second set of engagement members 490 distal
to the first proximal set of members 490, and rotated 90 degrees
about the longitudinal axis 401 from the first proximal set. The
anchor 400 is seen to have outer member 410 and actuation member
460. The outer member 410 is seen to have two pairs of engagement
member slots 430 for the engagement members 490. The outer member
410 is seen to have pin slots 440 for the ends 487 of pin 485. The
actuation member 460 has cavities (not shown) for mounting the
engagement members 490 and for receiving pin 485. Member 460 is
seen to have suture mounting hole 470 therethrough for receiving
suture 180. The additional engagement members 490 may assist in
providing additional pull-out strength. The anchor 400 is mounted
to an insertion instrument 200 and deployed in a manner
substantially similar to anchor 10.
[0061] An additional alternative embodiment of a suture anchor of
the present invention is seen in FIGS. 24-27. The anchor 500 is
similar to anchor 10. In this embodiment, however, the distal end
512 of the outer member 510 has an opening 514. Outer member 510 is
seen to be a tubular member having a passage or lumen 515
therethrough. The distal end 512 is optionally tapered in a
frustoconical fashion. The actuation member 550 is substantially
similar to actuation member 70, however the distal end 552 of
actuation member 550 is seen to have a distally extending nose
member 555 having a preferably substantially conical shape.
Actuation member is seen to have suture mounting opening 570
therethrough at the proximal end 554. The anchor 500 is seen to
have engagement members 590 mounted to the actuation member 550 and
extending into slots 540. The anchor 500 is also seen to have pin
560 having ends 562 extending into slots 530. When the anchor 500
is assembled by slidably mounting actuation member 550 in outer
member 510, the distal end 552 and nose section 555 are seen to
extend distally out through opening 514 in the undeployed position
as seen in FIGS. 24, 26 and 27. When in the deployed position as
seen in FIG. 25, the distal end 552 and nose 555 are retracted
proximally through opening 514 and are substantially or completely
contained within passage 515.
[0062] Although the suture anchors of the present invention are
designed to be used for soft tissue repair by facilitating the
affixation of soft tissue to bone, the anchors are not limited to
this use. For example the anchors may be used in other types of
surgical procedures including bladder neck suspensions procedures,
and plastic surgery procedures such a brow lifts.
[0063] The novel suture anchors of the present invention have many
advantages. In the anchors of the present invention, the arcs are
positioned within the profile of the anchor body and mechanically
secured with a pin. Since the arcs are not exposed, the user can
control the deployment of the arcs after the anchor body is placed
in bone. In addition, the profile of the device is reduced, and the
procedures can be performed through smaller incisions or cannulas.
The assembly of the device is simple. Also, the insertion and
locking of the device is achieved with two distinct operations.
First, the anchor is placed in bone at the desired location without
engaging the device. Secondly, the arcs are deployed and locked
into bone by applying tension to the suture. The design and
operation of the anchors of the present invention also provides for
the ability to withdraw the anchors after employment.
[0064] Although this invention has been shown and described with
respect to detailed embodiments thereof, it will be understood by
those skilled in the art that various changes in form and detail
may be made without departing from the spirit and scope of the
claimed invention.
* * * * *